From: KKrafka@Kemin.com
Sent: Friday, August 30, 2002 2:29 PM
To: fdadockets@oc.fda.gov
Subject: Docket No.---, Section 322 Recordkeeping, PHS and Bioterrorism Act of 2002
August 30, 2002
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Reference:
Docket No. _____________, Section 322, Recordkeeping
With regard Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PL 107-188), signed into law on June 12, 2002
To Whom It May Concern:
Kemin Industries, Inc. is a family-owned company established in 1961 with its worldwide headquarters in Des Moines, Iowa. Kemin has annual sales in excess of $150 million. We manufacture and market products that are regulated under the Federal Food, Drug and Cosmetic Act. Our product applications include, but are not limited to, uses in animal feeds, pet foods, human foods, dietary supplements and personal care items. We do business in over 60 countries around the world.
Following are our comments on Section 322 associated with the aforementioned Act:
Section 322 – We would like to obtain the specific list of FDA clearance numbers for the specific substances that may be imported, so that we are clear on what substances require an accompanying Certificate of Analysis or the functional equivalent.
We request clarification on the "imported for further processing disclosure requirement".
· What is FDA's position if the imported material is not intended for export, i.e., it will be sold in the US?
· What duty or requirement does a firm have to advise the FDA of a change, at the point the firm decides to market a product containing "imported material?"
· Does a firm have a continuing duty to notify the FDA when these substances are moved? In our case, we have adequate lot tracking records at our facilities to provide this information to FDA when requested and therefore, submitting additional correspondence may be redundant.
We seek clarification on the sentence from the statutory summary, "Further, this section requires the imported item be used in the manner declared when it is imported." In our business raw materials that are imported are incorporated into a variety of products in differing markets. We need to maintain a high degree of flexibility to remain profitable and competitive. We also recognize the need to maintain a safe food supply. We are seeking a balance between these two needs in the regulations.
· What duty does a firm have to the FDA by way of notice if the initial intended use of the imported material changes, e.g., a raw material is incorporated into a different product or is further processed for a different exported use?
· Will the FDA allow the initial intended use notice to be broad, e.g., this product will be incorporated into a variety of products used in the food supply chain?
· How will FDA classify the incoming raw material such that it will allow us the flexibility to use these raw materials both efficiently and economically?
In our business we regularly use the same raw materials from a foreign country for separate uses. It is one of the ways that we remain profitable and competitive. It is not uncommon for the same lot of raw material to end up in multiple finished product uses potentially for domestic or export sales. The regulations need to address same lot mixed use requirements. Because we adhere to GMP we have a high degree of ingredient traceability for our products. The issue is whether the regulations can be flexible enough to allow us to continue our manufacturing process without accumulating inventory because we failed to adequately predict future use of our imported raw material at the initial notice declaration.
We thank you in advance for the opportunity to comment on this pending legislation. If we can provide further information, please do not hesitate to contact me at 515/559-5347 or at the address listed above.
Sincerely,
KEMIN INDUSTRIES, INC.
Elizabeth A. Nelson
Corporate Counsel
EAN:kk
E-mailed by Kristi Krafka on behalf of Elizabeth A. Nelson, Kemin Industries, Inc.